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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Practicing on one of two SCI units at the SRAL
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up1 month
Awards & highlights
No Placebo-Only Group
EMRSCI Trial Summary
This trial will test the effects of the Enhanced Medical Rehabilitation program on engagement, intensity, and functional and psychosocial outcomes in patients with spinal cord injuries.
Eligible Conditions
- Spinal Cord Injury
EMRSCI Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Criterion: Working in one of the two SCI units at the SRAL
EMRSCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Function: Change in Continuity Assessment Record and Evaluation
Secondary outcome measures
Depression: Change in Patient Health Questionnaire-9
Life Satisfaction: Change in Satisfaction with Life Scale
Other outcome measures
Adherence/Fidelity: Change in Patient Satisfaction & Treatment Fidelity Survey
Adherence/Fidelity: Change in Therapist Adherence Rating Form
Baseline Comorbidity: Charlson Comorbidity Index
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
EMRSCI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Medical Rehabilitation (EMR)Experimental Treatment1 Intervention
Patients in the EMR group will also receive the recommended rehabilitation therapy, but they will receive therapy only from four therapists who are trained and supervised in EMR. The therapy sessions will follow EMR protocol. EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation.
Group II: Standard of Care (SOC)Active Control1 Intervention
The control group for this study will receive rehabilitation therapy that is recommended and provided by the current healthcare structure. The SOC group will receive therapy only from four therapists who are not trained and supervised in EMR. These therapists will be monitored (videotaped or observed) but will not be not asked to do anything differently with their patients. The investigators recognize that spillover of therapist EMR training to untrained therapists is a concern. Thus, the investigators will ask therapists in the EMR group to agree not to share any of the training with non-trained therapists over the course of the study, and the investigators will provide free EMR training to the non-trained therapists once the treatment phase of the study is complete.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
184 Previous Clinical Trials
14,383 Total Patients Enrolled
Washington University School of MedicineOTHER
1,899 Previous Clinical Trials
2,280,693 Total Patients Enrolled
Piper Hansen, OTDStudy DirectorShirley Ryan Ability Lab
1 Previous Clinical Trials
80 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Therapists who have experience working with patients with spinal cord injuries for at least six months.You are willing and able to participate in EMR training and supervision sessions.Therapists who have been treating spinal cord injuries for less than six months.Criterion: Working in one of the two SCI units at the SRALWorking in one of two SCI units at the SRAL.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Enhanced Medical Rehabilitation (EMR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities remaining for people to participate in this clinical trial?
"Evidentiary data hosted on clinicaltrials.gov illustrates that this particular experimental trial is not presently recruiting patients, despite its initial posting back in May 5th 2022 and update 3 days prior. However, if interested individuals are seeking to participate in a similar study, there are 904 other trials actively taking enrollees right now."
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Who else is applying?
What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Shirley Ryan Ability Lab
What portion of applicants met pre-screening criteria?
Met criteria
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